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The Medline ENFit Syringe is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to measure and administer enteral nutrition.

The Medline ENFit Syringe is a standard piston syringe which incorporates an ENFit connector. The device incorporates a female ENFit connector for connection to an enteral access device. The Medline ENFit Syringe is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a polyisoprene stopper. The Medline ENFit syringe comes with a cap as other predicate devices seen below. The Medline ENFit syringe will be sold as non-sterile. The performance of the Medline ENFit Syringe is equivalent to the predicate devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medline ENFit Syringe, structured according to your request. However, it's important to note that this document is a 510(k) summary, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria with detailed study designs and outcomes. Therefore, some of your requested information (like specific effect sizes for MRMC studies, sample sizes for training sets, and detailed expert qualifications) is not present in this type of FDA submission document.

Acceptance Criteria and Study for Medline ENFit Syringe (K160642)

The Medline ENFit Syringe's acceptance criteria and performance are primarily evaluated through its substantial equivalence to predicate devices, demonstrating its safety and effectiveness through adherence to established standards (ISO 80369-20 and ISO 7886-1) and general non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary, explicit numerical acceptance criteria with precise performance outcomes are generally not provided in this format. Instead, the document states that tests were conducted according to specified ISO standards and that the results "demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination." The performance is implied to have met the requirements of these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in this 510(k) summary. The summary only lists the types of tests performed (e.g., ISO 80369-20, ISO 7886-1, Biocompatibility). The sample sizes would have been determined by the requirements of the specific ISO standards or internal protocols for each test.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that these are non-clinical (laboratory and engineering) tests, the data would generally be prospective from controlled test environments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the studies described are non-clinical engineering and laboratory tests (e.g., liquid leakage, stress cracking, biocompatibility), not studies requiring expert interpretation of medical images or patient data to establish "ground truth." The "truth" for these tests is determined by adherence to physical performance metrics defined by international standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective interpretations (e.g., by experts) where disagreements need resolution. These are objective engineering and biological tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence."
• Effect size of human reader improvement: Not applicable, as no such study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, standalone performance was assessed through non-clinical testing. The summarized studies (ISO compliance, misconnection assessment, human factors validation, risk analysis, bioburden, metrology, stability, biocompatibility) evaluate the device's intrinsic characteristics and performance independent of a human operator's variable performance in a clinical diagnostic or interpretive context. For example, liquid leakage and stress cracking tests evaluate the device's physical integrity directly.

7. Type of Ground Truth Used

The "ground truth" for these non-clinical tests is established by:

• International Standards: The requirements and methodologies laid out in ISO 80369-20 (Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods) and ISO 7886-1 (Sterile hypodermic syringes for single use — Part 1: Syringes for manual use).
• Engineering Specifications: Internal design specifications and performance limits for metrology, stability, and other functional tests.
• Biological Endpoints: For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, or sensitization as defined by ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable because the device itself (Medline ENFit Syringe) is a physical medical device, not an AI algorithm or software that requires a training set. The term "training set" typically refers to data used to train machine learning models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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